Support from the Society for Vascular Surgery (SVS) and, later, funding from the SVS Foundation were integral to the BEST-CLI trial, said one of the landmark trial’s leaders.
BEST-CLI sought to determine the best revascularization treatment strategy—surgical or endovascular—for patients with chronic limb-threatening ischemia (CLTI). The trial was initially funded by the federal National Heart, Lung and Blood Institute at the National Institutes of Health (NIH). The Society for Vascular Surgery (SVS), the Society for Clinical Vascular Surgery (SCVS) and a host of other regional and national vascular societies contributed funds toward BEST-CLI. The SVS Foundation provided a $100,000 bridge grant at a critical juncture to ensure the trial could run through to its conclusion.
In late 2022, Novo Nordisk Foundation contributed $3.9 million to further fund the investigators to undertake a full analysis of the wealth of data the trial produced.
SVS members Matthew Menard, MD, and Alik Farber, MD, were two of the trial’s principal investigators. They first conceived of the idea in 2007, began preparations in 2009 and received funding in 2013. The trial randomized and followed 1,830 patients between 2014 and 2021, and the headline results were announced in late 2022. BEST-CLI found that surgical bypass with adequate single-segment great saphenous vein (GSV) is a more effective initial revascularization strategy for patients with CLTI who are deemed to be suitable for either an open or endovascular approach. The principal investigators also found that both strategies can be accomplished safely and are generally a very effective treatment for CLTI.
“The work of analyzing the large volume of data we have is ongoing,” said Farber. Many articles have been written about the trial since the initial publication of data. Vascular Specialist alone has published more than 20 follow-up articles on various facets of the BEST-CLI data. The interest, said Farber, indicates the trial’s significant impact and also highlights the SVS Foundation’s role in funding such critical research.
Menard indicated that “all of the things we have been able to achieve with regard to completion of the trial, as well as analysis and dissemination of the results directly stem from the funding we received during the early phase of our critical need. The SVS Foundation support represented the first contribution at a national society level. Its critical endorsement set the stage for other national societies to follow suit, and then for our industry partners to additionally champion our efforts. It is impossible to underestimate the impact of this critical initial sponsorship.”
Farber said that up to 40 supplemental secondary analyses have either been completed and published or are underway to bring additional important key findings to light.
These secondary analyses are helping to put the trial into appropriate context, by elucidating the results of the trial in different patient subgroups of interest. Farber and Menard are hoping the additional analyses will further help surgeons and other vascular care providers better understand the relevance of the trial to their own patients.
“These supplemental studies will help all of us better understand and interpret the results, and be better able to formulate treatment plans that are most suitable to individual CLTI patients,” Farber said.
SVS Foundation grants are meant to stimulate innovative research and thinking, said Menard. “It was always part of our goal to inspire the next generation of scientific investigators, and for them to build on the foundation established by BEST-CLI.”
They noted that high-quality research within the vascular surgical community is increasing. While judging BEST-CLI’s impact on this trend is difficult, Farber said, “we do think it was very important to demonstrate that vascular surgeons can lead high-quality trials and research. A number of trials that are currently works-in-progress are, in some ways, direct descendants of BEST.” He added that a great many SVS members are leading the secondary analyses of the BEST-CLI dataset. “It’s a very far-reaching effort,” he said.
What is one way of measuring Menard’s regard for the SVS Foundation? He’s now on the Foundation’s board of directors, and, as such, helped the body in its efforts to reach its fundraising goal before the year’s end. “There is no question that the support of the Society has been incredibly important to Alik and me as we journeyed through this trial experience. We have always been very aware that we would not have been able to achieve what we did without the incredible encouragement and assistance of both the Society leadership and its membership,” Menard said.
“The trial was completed because of the collective efforts of so many dedicated members of the Society, who, along with the wider vascular community, believed in what we were trying to do and, through their hard work and unwavering endorsement, brought it across the finish line.”
